162 mg of Aspirin for Prevention of Preeclampsia

NCT ID: NCT05221164

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2022-06-09

Brief Summary

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This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.

Detailed Description

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After screening to meet inclusion criteria, pregnant patients at the Family Medicine Clinic will be asked to take 162 mg aspirin daily for 6 months, starting at about 12 weeks gestation and continued until the end of pregnancy. They will be monitored every 4 weeks until week 28, then every 2 weeks until week 36, and then weekly from week 36 on. Participants will be screened at these visits for medication compliance (taking, missed doses, side effects, etc). Patients will be subject to lab work as is routinely indicated for preeclampsia.

At the end of the study period, accumulated study data will be compared with historical data from the Family Medicine Clinic on rates of preeclampsia and outcomes in patients taking 81 mg for preeclampsia prevention.

Conditions

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Preeclampsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention with 162 mg aspirin

Aspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic

Group Type EXPERIMENTAL

Aspirin 162 mg

Intervention Type DRUG

Daily aspirin 162 mg during pregnancy to prevent preeclampsia

Interventions

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Aspirin 162 mg

Daily aspirin 162 mg during pregnancy to prevent preeclampsia

Intervention Type DRUG

Other Intervention Names

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Aspirin

Eligibility Criteria

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Inclusion Criteria

* Any pregnant patient at Peoria FMC
* Hx of pre-eclampsia
* Multifetal gestation
* Chronic hypertension
* Type 1 or 2 diabetes
* Autoimmune disease
* Renal disease
* Nulliparity
* Obesity
* Family Hx of pre-eclampsia
* Sociodemographic characteristics
* Age \>= 35 years of age
* Personal history factors (LBW, SGA, \> 10-year pregnancy interval, adverse pregnancy outcomes

Exclusion Criteria

* At high risk of side effects from ASA therapy
* Hx of hemorrhagic stroke
* Hx of GI bleed, G6PD
* Liver disease
* NSAID or Salicylate allergy)
* Patients confirmed to be not compliant with therapy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois College of Medicine at Peoria

OTHER

Sponsor Role collaborator

UICOM Peoria Family Medicine Residency

UNKNOWN

Sponsor Role collaborator

Methodist Medical Center of Illinois

OTHER

Sponsor Role lead

Responsible Party

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Paul M Goldsmith, DO

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UnityPoint Clinic Family Medicine

Peoria, Illinois, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Paul Goldsmith, MD

Role: primary

816-838-8335

Andras Eder, MD

Role: backup

619-995-2529

References

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ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.

Reference Type RESULT
PMID: 29939940 (View on PubMed)

Rolnik DL, Wright D, Poon LCY, Syngelaki A, O'Gorman N, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Nicolaides KH. ASPRE trial: performance of screening for preterm pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Oct;50(4):492-495. doi: 10.1002/uog.18816. Epub 2017 Aug 24.

Reference Type RESULT
PMID: 28741785 (View on PubMed)

Atallah A, Lecarpentier E, Goffinet F, Doret-Dion M, Gaucherand P, Tsatsaris V. Aspirin for Prevention of Preeclampsia. Drugs. 2017 Nov;77(17):1819-1831. doi: 10.1007/s40265-017-0823-0.

Reference Type RESULT
PMID: 29039130 (View on PubMed)

Duley L, Meher S, Hunter KE, Seidler AL, Askie LM. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD004659. doi: 10.1002/14651858.CD004659.pub3.

Reference Type RESULT
PMID: 31684684 (View on PubMed)

Kumar N, Das V, Agarwal A, Pandey A, Agrawal S, Singh A. Pilot Interventional Study Comparing Fetomaternal Outcomes of 150 mg Versus 75 mg Aspirin Starting Between 11 and 14 Weeks of Pregnancy in Patients with High Risk of Preeclampsia: A Randomized Control Trial. J Obstet Gynaecol India. 2020 Feb;70(1):23-29. doi: 10.1007/s13224-019-01277-5. Epub 2019 Sep 20.

Reference Type RESULT
PMID: 32030002 (View on PubMed)

Levy G. Clinical pharmacokinetics of aspirin. Pediatrics. 1978 Nov;62(5 Pt 2 Suppl):867-72.

Reference Type RESULT
PMID: 724339 (View on PubMed)

Needs CJ, Brooks PM. Clinical pharmacokinetics of the salicylates. Clin Pharmacokinet. 1985 Mar-Apr;10(2):164-77. doi: 10.2165/00003088-198510020-00004.

Reference Type RESULT
PMID: 3888490 (View on PubMed)

Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15.

Reference Type RESULT
PMID: 27640943 (View on PubMed)

Rolnik DL, Nicolaides KH, Poon LC. Prevention of preeclampsia with aspirin. Am J Obstet Gynecol. 2022 Feb;226(2S):S1108-S1119. doi: 10.1016/j.ajog.2020.08.045. Epub 2020 Aug 21.

Reference Type RESULT
PMID: 32835720 (View on PubMed)

Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

Reference Type RESULT
PMID: 28657417 (View on PubMed)

Seidler AL, Askie L, Ray JG. Optimal aspirin dosing for preeclampsia prevention. Am J Obstet Gynecol. 2018 Jul;219(1):117-118. doi: 10.1016/j.ajog.2018.03.018. Epub 2018 Mar 26. No abstract available.

Reference Type RESULT
PMID: 29588190 (View on PubMed)

Other Identifiers

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1732470-3

Identifier Type: -

Identifier Source: org_study_id

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